FDA Label for Antiphlamine Pain Relieving

View Indications, Usage & Precautions

Antiphlamine Pain Relieving Product Label

The following document was submitted to the FDA by the labeler of this product Hanul Trading Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



Active Ingredient: Flurbiprofen 33mg


Inactive Ingredient



Inactive Ingredients: Methylparaben, Propylparaben, L-menthol, Propylene Glycol, Glycerin, Titanium Oxide, Kaolin, Sodium Carboxymethyl Cellulose, Dihydroxyaluminum Aminoacetate Hydrate, Disodium Edetate Hydrate, Gelatin, Sodium Polyacrylate, Polyacrylic Acid solution, Ferric Oxide, Butylhydroxytoluene, Purified water, felt, attachment felt, Polyethyleneterephthalate Separator, propyleneglycol monocaprylate, Sorbitan Oleate, tartaric acid


Purpose



Purpose: Topical Analgesic


Warnings



Warnings: For external use only Ask a doctor before use if you have redness over the affected area. Do not use: on wounds or damaged skin. Stop use and ask a doctor if excessive skin irritation occurs. Do not use if you are pregnant or breast feading. Do not use if you are allergic to any of the ingredients(Aspirin, Flurbiprofen) and stop use if rash, itching or allergic reaction develops.


Keep Out Of Reach Of Children



Keep out of reach of children: Keep out of reach of children to avoid accidental ingestion. If swallowed, get medical help or contact a Poison Control Center immediately. Children under 12 years of age: Ask a doctor Children under 30 month: Do not use


Indications & Usage



Indications & Usage: For the temporary relief of Shoulder Pain, Backache, Neuralgia, Arthralgia, Sore Muscles, Sprains, Bruises, Rheumatic Pain, and Fracture Pain.


Dosage & Administration



Dosage & Administration: Attach to the affected part, twice daily


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